The present disclosure is directed to apparatus, components, and methods of treatment for periodontal disease.
Periodontal disease is an umbrella term for a variety of dental conditions associated with either gingivitis or periodontitis. Gingivitis is an inflammation of the gingiva, commonly known as gums, that is commonly associated with poor oral hygiene and/or the hormonal state of the patient. If left untreated, gingivitis may develop into periodontitis.
Periodontitis is a bacterial disease in which the infection has progressed to involve the oral tissues that retain the teeth in the jawbone. With this disease the gums become red and inflamed. This condition, if untreated, results in damage to the ligaments and bone holding the teeth in place, and formation of pockets around the teeth. As the pockets become deeper, teeth loosen, to a point where they may fall out. The severity of periodontitis is determined by dentists and other dental practitioners, by measuring the depth of these pockets and reviewing x-rays of the teeth and jawbone.
Periodontal disease involves a different treatment protocol than other oral diseases. While many oral diseases can be treated with proper hygiene, fluoride, pastes, washes and rinses, periodontal disease is often more refractile to treatment. This is because of differences between the oral and periodontal cavities. The oral cavity is essentially an aerobic environment, constantly perfused by saliva. In contrast, the periodontal cavity is more anaerobic, and is perfused by plasma filtrate, known as xe2x80x9ccrevicular fluidxe2x80x9d. The growth of microorganisms within the periodontal cavity microenvironment may cause periodontal disease. As the disease progresses, the periodontal microenvironment becomes more anaerobic, and the flow of crevicular fluid increases.
Efforts to treat periodontal disease have met with limited degrees of success. This is because the site of the bacterial infections in the periodontal cavity are largely inaccessible to agents present in the oral cavity as well as agents provided to the oral cavity, such as mouthwashes, rinses and the like. Moreover, the increased outflow of crevicular fluid that accompanies periodontal disease inhibits therapeutic agents placed into the oral cavity from entering the pockets.
Oral systemic administration of antibiotics has been shown to be a useful method of controlling subgingival flora. However, because of side effects, such as those of the digestive system, oral systemic administration has had only limited use in treating periodontal disease. Oral systemic therapy also requires frequent dosing, so patient compliance is frequently a problem.
Recently, efforts have focused on delivering therapeutic agents directly to these pockets, in some cases, in a controlled release formulation. In general, administration of agents directly to the pocket permits higher local drug concentrations that can be achieved by systemic administration. Also, some agents such as tissue growth factors must be administered directly to the target site, i.e., the periodontal pocket. Also, as these products are typically administered by dental professionals patient compliance is not of moment here.
U.S. Pat. No. 4,175,326 to Goodson discloses the use of a drug-filled polymer hollow fiber. The disclosed delivery system is tied around a tooth and gently pressed below the margin of the gingiva so that it resides in the periodontal pocket, and can deliver tetracycline for a prolonged period, such as a week or more.
Although these devices may be able to dispense and appropriate drug for a time span of a week or more, they have not been widely used. This is because their application is difficult and time consuming and the device may be dislodged by the patient during tooth brushing, flossing or eating.
The aforementioned disadvantages were overcome by administration of microparticles in dry form to the periodontal pocket by use of an apparatus disclosed in U.S. Pat. Nos. 5,236,355, 5,366,733 and 5,622,498, all to Brizzolara, et al., all three patents are incorporated by reference herein. These patents disclose treating dental diseases by administration of dry microparticles to the periodontal pocket. Microparticles suitable for this purpose may have compositions, as described in U.S. Pat. Nos. 5,000,886, 5,143,661 and 5,500,228, all to Lawter, et al., all three of these patents incorporated by reference herein, and U.S. Pat. Nos. 5,236,355, 5,366,733 and 5,622,498, all to Brizzolara, et al., and may be produced by the methods disclosed in the aforementioned six U.S. patents.
The apparatus, components and methods disclosed herein improve on the contemporary art by providing a dispensing apparatus that can effectively deliver therapeutic agents directly to the periodontal pockets. The apparatus disclosed herein includes a reusable handle that is fitted with disposable cartridges, loaded with a composition, for example, a precise dose of a therapeutic agent. This saves the clinician time, eliminates guessing as to the proper dose, and reduces the amount of disposable instrumentation, making the process more economical. Additionally, the handle includes a body that has a configuration familiar to dental professionals, allowing them to use the disclosed apparatus with greater comfort and less training time. The cartridge provides for effective delivery of compositions, such as agents, as its tip is deformable, typically from a circular to an oval shape, either manually by the dental professional or upon contact with teeth or other tissues, whereby this flattened tip can penetrate deeply into pockets for quick and direct application of therapeutic agents.
An embodiment disclosed is directed to an apparatus for dispensing at least one material to a periodontal pocket. The apparatus has a barrel including a body portion and a tube portion, the tube portion extending from the body portion and including a tip configured for being deformed to at least one geometry different from its initial geometry. There is also a plunger, at least a portion of the plunger slideably housed within the barrel, the plunger configured for contacting a portion of an external force applying member. Additionally, there is a quantity of dry particles, for example a composition such as a therapeutic agent(s) or the like, and at least a portion of the dry particles are within the tip. A cap or closure member may be fitted over the tip to maintain the integrity of the composition until use is desired.
The apparatus is configured for receipt in an external force applying member, for example, a handle with a spring loaded shaft, in a temporarily locking arrangement. When use is desired, the apparatus snaps or locks into the handle and the spring loaded shaft is moved into contact with the plunger, pushing it, so as to push composition out of the tip into the periodontal pocket.
Another embodiment is directed to apparatus for dispensing material. This apparatus is formed of a barrel with a plunger, at least a portion of which is slideably housed in the barrel. The barrel includes a body portion and a tube portion, the tube portion extending from the body portion and including a tip configured for being deformed to at least one geometry different from its initial geometry. The plunger is configured for contacting a portion of an external force applying member.
The apparatus is configured for receipt in an external force applying member, for example, a handle with a spring loaded shaft, in a temporarily locking arrangement. When use is desired, the apparatus snaps or locks into the handle and the spring loaded shaft is moved into contact with the plunger in order to push it, to release a composition, previously loaded into at least the tip, out of the tip to the desired site.
Another embodiment is directed to a method for treating periodontal disease. This method involves providing an apparatus comprising, a force applying member adapted for receiving a barrel of a cartridge and a cartridge. The cartridge has a barrel including a body portion and a tube portion, the tube portion extending from the body portion, and the tube portion ends in a tip, that is configured for being deformed to at least one geometry different from its initial geometry. There is also a plunger, at least a portion of the plunger slideably housed within the barrel, the plunger configured for contacting a portion of the force applying member. There is also a quantity of dry particles, at least a portion of the dry particles being within the tip. The force applying member and cartridge are then placed into operative communication each other, for example, by a temporary locking engagement. The tip is then deformed, for example, to a substantially flattened geometry, and the deformed tip is moved into at least one periodontal pocket. The force applying member can have a portion of it (e.g., a spring-loaded shaft), moved to contact the plunger, moving the plunger so as to deliver the composition to the at least one periodontal pocket.